AAM White Paper Spotlights Legislative Path to Breaking Biosimilar Patent Barriers
In a white paper titled “Anatomy of a Biosimilar Patent Litigation: Problems and Solutions,” the Association for Accessible Medicines (AAM) and its Biosimilars Council shine a spotlight on the complex web of legal and regulatory barriers that delay access to affordable biosimilars and generic drugs. The publication highlights the extent to which brand-name drug manufacturers use “patent thickets” and serial litigation tactics—strategies that undermine competition, stall biosimilar market entry, and ultimately drive up costs for patients and payers.
According to the white paper, biologics make up just 15% of prescriptions in the US but represent over 50% of all prescription drug spending. Several of the highest-revenue drugs on the market are biologics, underscoring the stakes involved in opening this market to lower-cost competition. However, biosimilar developers often face a staggering number of legal obstacles: for just 6 recently approved biosimilars, brand companies asserted between 11 and 65 patents per product. These tactics significantly hinder or delay biosimilar entry, even after products have cleared regulatory hurdles.
AAM President and CEO John Murphy III emphasized the urgent need for reform: “Brand patent abuse and patent thickets deter patient access to more affordable medicines,” he said. “Congress can take steps now to proactively reform the patent system by passing bipartisan legislation that would save American patients and the healthcare system billions.”
The white paper outlines 3 core legislative proposals currently under consideration in Congress that aim to address the misuse of the patent system.
One such measure is the Ending The Hedge to Inflate Claims (ETHIC) Act, H.R. 3269, which seeks to cap the number of patents that can be asserted in biologics litigation. The proposed reform would restrict brand companies to asserting only one patent from a terminally disclaimed patent family. This would directly limit the ability of brand manufacturers to string together slight patent variations in an effort to prolong exclusivity.
Another key issue is the right to settle patent disputes. The white paper critiques Senate bill S. 1096, which could severely limit the ability of biosimilar manufacturers to reach procompetitive patent settlements. Without the option to settle, the already significant costs associated with biosimilar development—ranging from $100 million to $300 million per product—would increase further, potentially deterring market entry altogether. The paper argues that reasonable, lawful settlements can play a critical role in facilitating timely access to lower-cost alternatives.
Finally, the paper highlights the Skinny Labels, Big Savings Act (S. 43), which would establish a statutory safe harbor for labeling carve-outs. This proposal aims to mitigate the fallout from court decisions in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc. and Amarin v. Hikma, which upended longstanding US Food and Drug Administration (FDA) practices allowing generic manufacturers to exclude certain patented uses from their labeling. Reinforcing this protection would restore a pathway for generics and biosimilars to reach market without infringing on method-of-use patents.
For payers and managed care organizations, these reforms, if enacted, could have significant implications for coverage policy. Reduced legal uncertainty would support earlier biosimilar launches, improving formulary diversity and cost-control opportunities. Enhanced access to affordable biologics could also shift prescribing patterns and influence total cost of care models.
Reference
- Association for Accessible Medicines. Anatomy of a biosimilar patent litigation: problems and solutions. White paper. July 2025. Accessed August 18, 2025. https://accessiblemeds.org/wp-content/uploads/2025/07/White-Paper-Anatomoy-of-Biosimilar-Patent-Legislation-July-2025.pdf
- Association for Accessible Medicines. White paper analyzes problems and solutions to patent abuses. July 8, 2025. Accessed August 18, 2025. https://accessiblemeds.org/resources/press-releases/patent-thickets-and-litigation-abuses-hinder-all-biosimilars/
